MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. TURNPIKE SPIRAL; CATHETER

Model Number	5640
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
A turnpike spiral was inserted into a calcified vessel.The turnpike spiral's tip locked up on the wire and the tip came off in the patient on the wire.The tip was stuck to the wire; tip and guidewire removed in tandem.
Additional Manufacturer Narrative
Evaluation of turnpike spiral was returned to vsi for evaluation.The catheter showed signs of biological contamination.The distal tip was severely damaged and fragments of the tungsten were torn but remained intact.The tip is intact but shows signs of damage consistent with rotating in a calcified vessel.The tip was also twisted and deformed.There were no pieces missing from the catheter.The event description along with the returned product evaluation provided sufficient evidence to determine that the most likely root cause was damage during use.The event description describes the catheter was being used in a calcified vessel.The turnpike spiral traveler was reviewed.There were no nonconformances related to this lot.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6254379
• Report Number: 2134812-2017-00005
• Device Sequence Number: 13562900
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: +M20656400/$$3180908598339C
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K14065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/08/2018
• Device Model Number: 5640
• Device Lot Number: 598339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 02/14/2017
• Patient Sequence Number: 1